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A pacemaker-like device currently used to treat epilepsy is being evaluated
as a possible new treatment for depression by UCSD Healthcare psychiatrists.
Known as the Vagus Nerve Stimulator, the device will be implanted in 10 to 15
severely depressed San Diegans who have not responded to medication or
psychotherapy.

According to national mental health organizations, 17-19 million Americans
suffer from depression and an estimated one to three million are deemed
treatment-resistant. These individuals get little or no help from medications,
visits to the doctor, and shock treatments.

Mark Rapaport, M.D., UCSD associate professor of psychiatry, a staff physician
at the San Diego Veterans Affairs Health Care System, and principal investigator
of the San Diego site, said the Vagus Nerve Stimulator seems to help about 40%
of the patients who participated in the University of Texas open-treatment pilot
study published in the December 1999 journal Biological Psychiatry. "Those
severely depressed patients who did have a positive response had a remarkable
change in their lives," he said.

Since the nerve stimulator was approved by the Food and Drug Administration in
1997 for the treatment of epilepsy, more than 7,000 patients have used the
device. About the size of a stopwatch, the Vagus Nerve Stimulator is implanted
in the upper chest during outpatient surgery. Guide wires are tunneled up the
neck and wrapped around the left vagus nerve, which connects to several parts of
the brain that are involved in mood and emotion.

The current study is a double-blind trial where all patients will have the
stimulator off for a certain period of time followed by nine months of follow-up
monitoring with the stimulator active. This study will occur in 20 sites in the
US and the patients must meet rigorous entry criteria. The current study is
funded by Cyberonics, a Houston, Texas company that manufacturers the Vagus
Nerve Stimulator.

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